Transforming the lives of our patients and their families through innovative science and compassionate care.
IMPORTANT MESSAGE FOR TRIAL PARTICIPANTS REGARDING NATIONWIDE RECALL OF SELECT LOTS of EpiPen and EpiPen Jr.
As of Friday, March 31, 2017, Mylan announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).
According to a company statement, this recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.
The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector with lot numbers and expiration dates in this chart.
Visit http://www.mylan.com/en/epipenrecall for more information on returning and replacing recalled product.
If you have a life threatening allergic reaction and you don't have a different auto-injector available, you should still use your EpiPen or EpiPen Jr. Then call 911 and proceed to the emergency room, and then call the on-call clinician for our Center.
Trial participants, please reach out to your study coordinator if you have any concerns.
Julia and David Koch Make Visionary $10 Million Gift to Establish New Clinical Research Unit for Allergy and Asthma at Lucile Packard Children’s Hospital Stanford and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University
On February 15, 2017, Julia and David Koch announced a generous gift of $10 million to establish a new unit at Lucile Packard Children’s Hospital Stanford for clinical research. The unit will operate within the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, which is home to the groundbreaking allergy and asthma clinical trials led by Kari Nadeau, MD, PhD.
Nadeau directs the Sean N. Parker Center for Allergy and Asthma Research, one of the world’s first coordinated efforts to combine lab research, clinical research, and compassionate patient care across all types of allergies. While Nadeau conducts lab research on the Stanford University campus, she currently conducts clinical research off campus at a Packard Children’s-licensed unit within El Camino Hospital in Mountain View.
Thanks to the Kochs’ generous gift, Nadeau and her team will expand their clinical research to a redesigned unit within Lucile Packard Children’s Hospital Stanford in 2018. Packard Children’s is currently nearing completion on a major expansion which will subsequently free up space for Nadeau’s research. With its location on the Stanford campus, the new site for clinical trials will enable Nadeau’s team to expand research to better understand the underlying cause of allergies and to develop a lasting cure. It will also bring them within walking distance of Nadeau’s research lab and other physicians and researchers working together at Stanford to advance allergy and asthma research.
"We made this gift with the goal of bringing better and safer treatments to more children and adults suffering from dangerous allergies," said Julia F. Koch, whose family has experienced firsthand the anxiety of living with food allergies, as well as the life-changing effects of a clinical trial to safely desensitize the allergies. "Through this gift, we hope to advance innovative research and allow more individuals and families to enjoy fuller lives."
“Mr. and Mrs. Koch’s thoughtful investment will have a tremendous impact on the care and treatment we provide for children and families with allergies and asthma,” says Nadeau. “Children and families with food allergies often live in constant fear of life-threatening reactions. We are determined to use innovative research and provide compassionate care to move the science forward in a transformative way to ensure a safer future. I am tremendously grateful to Mr. and Mrs. Koch for their gift to establish a new clinic, which will play an integral role in advancing this work at the Sean N. Parker Center for Allergy and Asthma Research. Together, we will make a difference not only for those participating in clinical trials at Lucile Packard Children’s Hospital Stanford, but for all individuals with allergies who may one day benefit from research toward better, safer, and lasting therapies.”
Allergies and asthma are on the rise around the world, including in the United States. Allergies occur in all ages and can range from allergic conjunctivitis, allergic rhinitis, allergic asthma, and allergic gastrointestinal disease to drug allergies and food allergies. Severe food allergies are a growing epidemic, with rates having doubled in the last decade. About one in three Americans suffer from some form of allergy, and doctor-diagnosed food allergies affect one in 12 American children under the age of 21 and one in about 50 adults. Of those individuals with a food allergy, approximately 25 percent will have a near-fatal anaphylactic reaction at some point in their lives. It is estimated that $25 billion is spent annually on reactive food allergy care.
Nadeau, who is also the Naddisy Foundation Professor of Medicine and Pediatrics at Stanford University School of Medicine, developed the first combination multi-food-allergy therapy for patients with more than one food allergy. The new unit at Packard Children’s will put her team within closer proximity to colleagues in immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics at Stanford University who are contributing to this important collaborative work.
For more information, contact Jennifer Yuan, Lucile Packard Foundation for Children’s Health
National Academies of Sciences, Engineering and Medicine release comprehensive report on Food Allergy
The National Academies of Sciences, Engineering, and Medicine convened an expert, ad hoc committee to examine critical issues related to food allergy. The resulting report, released on November 30, 2016, Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy, collects and evaluates the scientific evidence on the prevalence, origins, diagnosis, prevention, and management of food allergy and makes recommendations to policy makers, industry leaders, and others to bring about a safe environment for those with food allergy.
Following is a statement by Dr. Stephen Galli, the Mary Hewitt Loveless, M.D. Professor in the Stanford School of Medicine and Professor of Pathology and of Microbiology and Immunology, who served as a member of the Institute of Medicine committee that wrote this report.
It was a privilege and honor to serve on this committee, and to work in producing the report with the other members of the committee, the dedicated and effective national academies staff, and the many private and federal sponsors of this important effort.
As described in the brief summary of the report that was released today, and as presented in substantial detail in the report itself, the committee concluded that the time is now to undertake a number of measures that, if enacted successfully, promise to improve markedly the quality of life of those suffering from food allergies. Succeeding in this effort will require the prompt and responsive cooperation of many stakeholders, including those federal and state agencies whose thoughtful work will be required to effect these changes. I encourage all those who are interested in the problem of food allergy to read the report and to do their part in encouraging the rapid implementation of the committee's recommendations.
As important as implementing the report's recommendations will be in addressing this serious problem, finally succeeding in finding ways to effectively treat, or ideally to prevent the occurrence, of food allergies will require innovative research to advance our understanding of the origins of this disorder, and to devise better ways to prevent or treat it. I anticipate that, with the visionary leadership of Kari Nadeau, the Sean N. Parker Center for Allergy & Asthma Research at Stanford will continue to contribute importantly to the world-wide efforts, by talented investigators at many institutions, to bring relief to those suffering from this terrible disorder.
Hartman Family Foundation Challenge grant Matched
We met our match! We are thrilled to announce that we have raised $1.2 million to meet our challenge grant from the Hartman Family Foundation. Through the generous 1-to-1 match from Kim and Alan Hartman's Foundation and so many other generous donors, we raised a total of $2.4 million to directly support this major step to making a food allergy “vaccine” a reality.
Stay tuned for updates about this groundbreaking study to test an approach called peptide “vaccine” immunotherapy. Similar to a tuberculosis test, the food allergy “vaccine” would go under the skin to stimulate a specific set of immune cells and permanently reduce or suppress allergic reactions.
“This could be a breakthrough for our field and we are grateful to the Hartman Foundation for making it possible through their gift,” said Dr. Kari Nadeau, Director of the Sean N. Parker Center for Allergy & Asthma Research at Stanford University.
94% of Center funding is provided by philanthropy. Ongoing support helps patients and families everyday by advancing the science and research for groundbreaking clinical trials, educating and disseminating protocol across the nation, building infrastructure for the Center, and so much more. To learn more about our important funding priorities, contact Lindsey Hincks.
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University joins forces with Stanford's Division of Pulmonary and Critical Care Medicine
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University has recently joined Stanford’s Division of Pulmonary and Critical Care Medicine (PCCM). Previously the Sean N. Parker Center for Allergy Research, the expanded Center now encompasses asthma research and patient care.
“This is exciting news for our Center,” explains Center Director Dr. Kari Nadeau. “There are common mechanisms underlying allergy, asthma, and lung disease and by joining forces with PCCM, we can collaboratively advance our understanding of these diseases.”
The integration also strengthens PCCM’s research mission to support basic science and innovative clinical approaches for the prevention, early detection, diagnosis, and treatment of respiratory diseases and critical illnesses.
Under the leadership of Dr. Kari Nadeau, the Sean N. Parker Center for Allergy and Asthma Research conducts cutting-edge research to develop new innovative diagnostic tests and treatments for patients with asthma and allergies. The Center enrolls patients who represent a diverse group of ethnicities and socioeconomic backgrounds, offering equal opportunity to all eligible individuals with allergies and asthma.
PCCM, led by Division Chief Dr. Mark Nicolls, will now include the Sean N. Parker Center for Allergy and Asthma Research in addition to specialized programs for the treatment and management of interstitial lung disease, lung transplantation, cystic fibrosis, pulmonary hypertension, interventional pulmonology, lymphangioleiomyomatosis, lung nodule surveillance and cancer detection, and emphysema.
For more information about PCCM, please visit http://med.stanford.edu/pulmonary.html. For the latest information on trials currently being offered at Stanford and other institutions, please visit www.clinicaltrials.gov.